Successful cell and gene therapy manufacturing is dependent on high-quality reagents to ensure safety, efficacy, and batch-to-batch consistency. Despite arising guidance in this area, there is no official certification given for the manufacturing of GMP grade raw materials, neither in Europe nor in the USA.
Since this kind of GMP certification is not likely to be announced in the near future, manufacturers of raw materials have to identify critical quality requirements to meet increasing quality and safety concerns.
We propose and apply the following three critical quality standards for the manufacturing of GMP grade raw materials:
• Raw material and supplier qualification
• ADCF Preclinical and GMP cytokines
• Serum-free media
• Documented evidence of purity, potency, consistency, and stability
• Full documentation
• Compliance to USP <1043>, Ph. Eur. 5.2.12, ISO 20399:2022
• Expert technical and regulatory support
Safety
GMP Compliance
Regulatory Compliance & Support
• Raw material and supplier qualification
• ADCF Preclinical and GMP cytokines
• Serum-free media
• Documented evidence of purity, potency, consistency, and stability
• Full documentation
• Compliance to USP <1043>, Ph. Eur. 5.2.12, ISO 20399:2022
• Expert technical and regulatory support
Sartorius CellGenix has a rich history of producing premium-grade raw and ancillary materials; our GMP grade products allow for the safe use in clinical trials and commercial manufacturing in accordance with the guidelines set by the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and ISO 20399:2022.
CellGenix® GMP Cytokines
CellGenix® GMP Serum-free Media
Technotes
Raw Material Validation: ask the experts